Sleeve Gastrectomy Versus Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Wilford Hall Medical Center
ClinicalTrials.gov Identifier:
NCT00965302
First received: August 24, 2009
Last updated: December 19, 2012
Last verified: August 2009
  Purpose

The investigators plan to randomize mild to moderately obese (BMI 30-34.9) subjects to medical management (diet, exercise, and best medical therapy) versus sleeve gastrectomy with medical management, with a primary endpoint of diabetes remission (normal fasting glucose, off medications and insulin) at one year. Sleeve gastrectomy (also called greater curvature gastrectomy, vertical sleeve gastrectomy, and sleeve gastroplasty) involves stapled resection of the gastric fundus. Secondary endpoints include weight loss, improvement in hypertension, sleep apnea, c-reactive protein, and fasting lipid profile.


Condition Intervention
Diabetes Mellitus, Type 2
Obesity
Procedure: Laparoscopic sleeve gastrectomy
Behavioral: Intensive medical management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sleeve Gastrectomy vs Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients

Resource links provided by NLM:


Further study details as provided by Wilford Hall Medical Center:

Primary Outcome Measures:
  • Diabetes remission [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Obstructive sleep apnea remission [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Fasting lipid profile [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • c-reactive protein [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: August 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intensive medical management of Type 2 DM
Intensive medical management of Type II diabetes will include visits every three months for a year with an endocrinologist, with lifestyle counseling, weight management, regular exercise, and glucose control forming the core of the medical therapy.
Behavioral: Intensive medical management
Intensive medical therapy for Diabetes mellitus, Type 2, will include weight management counseling, exercise, glucose control, and healthy dietary choices.
Experimental: Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy is performed as part of a bariatric surgical program emphasizing healthy dietary choices, regular exercise, and glucose control.
Procedure: Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy, also known as vertical sleeve gastrectomy, sleeve gastroplasty, or sleeve gastrectomy, will be performed over a 32 to 40 French sizing bougie.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes mellitus, Type 2
  • Body Mass Index (BMI) 30-34.9
  • Able to understand and comply with study process

Exclusion Criteria:

  • Pregnancy
  • Prior bariatric surgery
  • Diabetes mellitus, Type 1
  • Renal impairment
  • Cirrhosis or portal hypertension
  • Diabetes secondary to a specific condition
  • Recent internal malignancy (<5 years)
  • Recent major vascular event
  • Drug or alcohol dependence
  • Uncontrolled psychiatric disease
  • Crippling cardiopulmonary disease
  • Prohibitive anatomic features (extensive prior surgery, giant paraesophageal hernia)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965302

Locations
United States, Texas
Wilford Hall Medical Center
San Antonio, Texas, United States, 78236
Sponsors and Collaborators
Wilford Hall Medical Center
Investigators
Principal Investigator: Jason M Pfluke, MD Wilford Hall Medical Center, United States Air Force
  More Information

Publications:
Responsible Party: Jason M. Pfluke, MD MAJ USAF MC, Wilford Hall Medical Center, United States Air Force
ClinicalTrials.gov Identifier: NCT00965302     History of Changes
Other Study ID Numbers: FWH20090068H
Study First Received: August 24, 2009
Last Updated: December 19, 2012
Health Authority: United States: Federal Government

Keywords provided by Wilford Hall Medical Center:
Obesity
Diabetes mellitus, Type 2
Sleeve gastrectomy
Metabolic surgery

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014